Dataset Information

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.

ABSTRACT:

Background

Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.

Method

We designed a single center, randomized, placebo controlled, double-blind phase II randomized clinical trial. One hundred and two adult patients hospitalized within 2 weeks of discharge due to acute decompensated HF with reduced ejection fraction (HFrEF) and systemic inflammation (high sensitivity of C-reactive protein > 2 mg/L) will be randomized in 2:1 ratio to receive anakinra or placebo for 24 weeks. The primary objective is to determine the effect of anakinra on peak oxygen consumption (VO₂) measured at cardiopulmonary exercise testing (CPX) after 24 weeks of treatment, with placebo-corrected changes in peak VO₂ at CPX after 24 weeks (or longest available follow up). Secondary exploratory endpoints will assess the effects of anakinra on additional CPX parameters, structural and functional echocardiographic data, noninvasive hemodynamic, quality of life questionnaires, biomarkers, and HF outcomes.

Discussion

The current trial will assess the effects of IL-1 blockade with anakinra for 24 weeks on cardiorespiratory fitness in patients with recent hospitalization due to acute decompensated HFrEF.

Trial registration

The trial was registered prospectively with ClinicalTrials.gov on Jan 8, 2019, identifier NCT03797001.

SUBMITTER: Van Tassell B

PROVIDER: S-EPMC9198622 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.

Van Tassell Benjamin B Mihalick Virginia V Thomas Georgia G Marawan Amr A Talasaz Azita H AH Lu Juan J Kang Le L Ladd Amy A Damonte Juan Ignacio JI Dixon Dave L DL Markley Roshanak R Turlington Jeremy J Federmann Emily E Del Buono Marco Giuseppe MG Biondi-Zoccai Giuseppe G Canada Justin M JM Arena Ross R Abbate Antonio A

Journal of translational medicine 20220615 1

<h4>Background</h4>Heart failure (HF) is a global leading cause of mortality despite implementation of guideline directed therapy which warrants a need for novel treatment strategies. Proof-of-concept clinical trials of anakinra, a recombinant human Interleukin-1 (IL-1) receptor antagonist, have shown promising results in patients with HF.<h4>Method</h4>We designed a single center, randomized, placebo controlled, double-blind phase II randomized clinical trial. One hundred and two adult patients ...[more]

PMID: 35706006

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Dataset Information

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.

Background

Method

Discussion

Trial registration

Publications

Rationale and design of interleukin-1 blockade in recently decompensated heart failure (REDHART2): a randomized, double blind, placebo controlled, single center, phase 2 study.

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